FDA 510(k)

Xenco Medical InterAlign Cervical Interbody System

K-Number: K223059 · 2023-06-07

Decision Date2023-06-07

Product CodeOVE

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Xenco Medical InterAlign Cervical Interbody System is a medical device manufactured by Xenco Medical, LLC. It received FDA 510(k) clearance on 2023-06-07 under approval number K223059. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Xenco Medical InterAlign Cervical Interbody System?

Xenco Medical InterAlign Cervical Interbody System is a medical device that received FDA 510(k) clearance on 2023-06-07. It is manufactured by Xenco Medical, LLC. The 510(k) number is K223059.

When was Xenco Medical InterAlign Cervical Interbody System approved by the FDA?

Xenco Medical InterAlign Cervical Interbody System received FDA 510(k) clearance on 2023-06-07, under approval number K223059.

What company makes Xenco Medical InterAlign Cervical Interbody System?

Xenco Medical InterAlign Cervical Interbody System is manufactured by Xenco Medical, LLC.

What is the FDA product code for Xenco Medical InterAlign Cervical Interbody System?

The FDA product code for Xenco Medical InterAlign Cervical Interbody System is OVE.

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Related PubMed Literature

PMID: 42175114 Make Open Source Compliant: Validation in Non-Interventional Clinical Studies. Studies in health technology and informatics (2026) PMID: 42174947 Aligning AI-Native 6G Healthcare Systems with EU Ethical and Legal Frameworks. Studies in health technology and informatics (2026) PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 41879133 Medical Device Regulation - Who Does the FDA Serve? The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics (2026)

Other Devices by Xenco Medical, LLC

K160313Xenco Medical Cervical Interbody System K161478Xenco Medical Posterior Cervical System K160986Xenco Medical Pedicle Screw System K170611SETx Pedicle Screw System K173933Sorrento Bioglass Bone Graft Substitute K180373CancelleX Porous Titanium Lumbar Interbody Device

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Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife Spine, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.